生物試劑報關清關的范圍 申請條件及所需材料

　　NO.1辦理范圍

　　NO.1 Scope of processing

　　《中華人民共和國國境衛生檢疫法實施細則》第十一條規定：“入境、出境的微生物、人體組織、生物制品、血液及其制品等特殊物品的攜帶人、托運人或者郵遞人，必須向衛生檢疫機關申報并接受衛生檢疫，憑衛生檢疫機關簽發的特殊物品審批單辦理通關手續。未經衛生檢疫機關許可，不準入境、出境。”

　　The People's Republic of China Border Health and Quarantine Law Implementation Rules,Article 11:"Entry and exit of microorganisms,human tissue,biological products,blood and its products and other special items of the carrier,shipper or mail carrier,must be declared to the health and quarantine authorities and accept health quarantine,with the health and quarantine authorities issued by the approval of special items for customs clearance procedures.Without the permission of the health and quarantine authorities,are not allowed to enter or leave the country."

　　微生物是指病毒、細菌、真菌、放線菌、立克次氏體、螺旋體、衣原體、支原體等醫學微生物菌（毒）種及樣本以及寄生蟲、環保微生物菌劑。

　　Microorganisms are viruses,bacteria,fungi,actinomycetes,rickettsia,spirochetes,chlamydia,mycoplasma and other medical microbial bacteria(toxins)and samples,as well as parasites,environmental microbial agents.

　　人體組織是指人體細胞、細胞系、胚胎、器官、組織、骨髓、分泌物、排泄物等。

　　Human tissue refers to human cells,cell lines,embryos,organs,tissues,bone marrow,secretions,excretions,etc.

　　生物制品是指用于人類醫學、生命科學相關領域的疫苗、抗毒素、診斷用試劑、細胞因子、酶及其制劑以及毒素、抗原、變態反應原、抗體、抗原-抗體復合物、核酸、免疫調節劑、微生態制劑等生物活性制劑。

　　Biological products refer to vaccines,antitoxins,diagnostic reagents,cytokines,enzymes and their preparations as well as toxins,antigens,allergens,antibodies,antigen-antibody complexes,nucleic acids,immunomodulators,microecological preparations and other biologically active preparations used in human medicine and life science related fields.

　　血液是指人類的全血、血漿成分和特殊血液成分。

　　Blood refers to human whole blood,plasma components and special blood components.

　　血液制品是指各種人類血漿蛋白制品。

　　Blood products refer to various human plasma protein products.

　　NO.2申請條件

　　NO.2 application conditions

　　（一）法律法規規定須獲得相關部門批準文件的，應當獲得相應批準文件（見申請材料）；

　　(A)laws and regulations to obtain the relevant departmental approval documents,should obtain the appropriate approval documents(see application materials).

　　（二）具備與出入境特殊物品相適應的生物安全控制能力。

　　(B)with the entry and exit of special items to adapt to the biosafety control capabilities.

　　NO.3申請材料

　　NO.3 Application materials

　　（一）申請特殊物品審批的，貨主或者其代理人應當按照以下規定提供相應材料：

　　(A)the application for approval of special articles,the owner or his agent shall provide the appropriate materials in accordance with the following provisions.

　　2.出入境特殊物品描述性材料，包括特殊物品中英文名稱、類別、成分、來源、用途、主要銷售渠道、輸出輸入的國家或者地區、生產商等；

　　2.entry and exit of special articles descriptive materials,including the name of special articles in English and Chinese,categories,ingredients,sources,uses,major sales channels,export and import of countries or regions,manufacturers,etc..

　　3.入境用于預防、診斷、治療人類疾病的生物制品、人體血液制品，應當提供國務院藥品監督管理部門發給的進口藥品注冊證書；

　　3.entry for the prevention,diagnosis,treatment of human diseases of biological products,human blood products,should provide the State Council drug supervision and management departments issued by the registration certificate of imported drugs.

　　4.入境、出境特殊物品含有或者可能含有病原微生物的，應當提供病原微生物的學名（中文和拉丁文）、生物學特性的說明性文件（中英文對照件）以及生產經營者或者使用者具備相應生物安全防控水平的證明文件；

　　4.entry,exit special items containing or may contain pathogenic microorganisms,should provide the scientific name of the pathogenic microorganisms(Chinese and Latin),biological characteristics of descriptive documents(in English and Chinese)and the production and operators or users with the appropriate level of biosecurity control documents.

　　5.出境用于預防、診斷、治療的人類疾病的生物制品、人體血液制品，應當提供藥品監督管理部門出具的銷售證明；

　　5.outbound for the prevention,diagnosis and treatment of human diseases of biological products,human blood products,should provide a certificate of sale issued by the Drug Administration.

　　6.應當取得人類遺傳資源管理部門出具的批準文件，海關對有關批準文件電子數據進行系統自動比對驗核；

　　6.should obtain the approval documents issued by the human genetic resources management department,the customs of the relevant approval documents electronic data for automatic system matching verification.

　　7.使用含有或者可能含有病原微生物的出入境特殊物品的單位，應當提供與生物安全風險等級相適應的生物安全實驗室資質證明，BSL-3級以上實驗室必須獲得國家認可機構的認可；

　　7.The use of special entry and exit units containing or may contain pathogenic microorganisms,should provide a biosafety laboratory qualification certificate appropriate to the level of biosafety risk,BSL-3 level laboratory must be accredited by the national accreditation body.

　　8.出入境高致病性病原微生物菌（毒）種或者樣本的，應當提供省級以上人民政府衛生主管部門的批準文件。

　　8.Entry and exit of highly pathogenic pathogenic microorganisms bacteria(viruses)or samples,should provide the approval documents of the competent health departments of the provincial government or above.

　　（二）申請人為單位的，首次申請特殊物品審批時，除提供本指南第（一）項所規定的材料以外，還應當提供單位基本情況，如單位管理體系認證情況、單位地址、生產場所、實驗室設置、倉儲設施設備、產品加工情況、生產過程或者工藝流程、平面圖等；實驗室生物安全資質證明文件。

　　(B)the applicant is a unit,the first application for approval of special items,in addition to providing the materials specified in paragraph(a)of this guide,should also provide basic information about the unit,such as the unit management system certification,unit address,production sites,laboratory settings,storage facilities and equipment,product processing,production processes or processes,floor plans,etc.;laboratory biosafety qualification documents.

　　申請人為自然人的，應當提供身份證復印件。出入境病原微生物或者可能含有病原微生物的特殊物品，其申請人不得為自然人。

　　The applicant is a natural person,should provide a copy of the ID card.Entry and exit of pathogenic microorganisms or special items that may contain pathogenic microorganisms,the applicant shall not be a natural person.